Volkmann, Elizabeth R;
Kreuter, Michael;
Hoffmann-Vold, Anna M;
Wijsenbeek, Marlies;
Smith, Vanessa;
Khanna, Dinesh;
Denton, Christopher P;
... SENSCIS trial investigators; + view all
(2022)
Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial.
Rheumatology
, Article keac091. 10.1093/rheumatology/keac091.
(In press).
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Abstract
OBJECTIVE: To investigate the rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) with and without cough or dyspnoea in the SENSCIS trial. METHODS: Patients in the SENSCIS trial were randomized to receive nintedanib or placebo. Subgroups with and without cough or dyspnoea at baseline were defined by responses to the St. George's Respiratory Questionnaire. RESULTS: At baseline, 114/575 patients (19.8%) did not have cough and 172/574 patients (30.0%) did not have dyspnoea. In the placebo group, the rate of FVC decline over 52 weeks was similar in patients with and without cough (-95.6 and -83.4 ml/year, respectively) or dyspnoea (-95.8 and -87.7 ml/year, respectively). The effect of nintedanib vs placebo on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough (difference: 74.4 [95% CI -11.1, 159.8] vs 31.5 [-11.1, 74.1]) and without than with dyspnoea (79.8 [9.8, 149.7] vs 25.7 [-19.9, 71.3]), but interaction p-values did not indicate heterogeneity in the treatment effect between these subgroups (p= 0.38 and p= 0.20, respectively). CONCLUSION: In the placebo group of the SENSCIS trial, the rate of FVC decline was similar irrespective of the presence of cough or dyspnoea at baseline. The effect of nintedanib on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough or dyspnoea at baseline, but no statistically significant heterogeneity was observed between the subgroups. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02597933.
| Type: | Article |
|---|---|
| Title: | Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/rheumatology/keac091 |
| Publisher version: | https://doi.org/10.1093/rheumatology/keac091 |
| Language: | English |
| Additional information: | © The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
| Keywords: | Connective tissue diseases, nintedanib, scleroderma, systemic, vital capacity |
| UCL classification: | UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10144301 |
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